Atlas FDA

ADKINS STRUT

FDA 510(k) clearance K091058 · decided 2009-07-22

Clearance details

K-number
K091058
Device name
ADKINS STRUT
Applicant
Biomet Microfixation, Inc.
Decision
Substantially Equivalent
Date received
2009-04-13
Decision date
2009-07-22
Days to decision
100 days
Clearance type
Traditional
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Jacksonville, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Total Temporomandibular Joint Replacement System (P020016/S011)Biomet Microfixation, Inc.2019-12-17
TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM (P020016/S008)Biomet Microfixation, Inc.2017-06-08
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S007)Biomet Microfixation, Inc.2014-12-09
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S006)Biomet Microfixation, Inc.2012-03-15
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S005)Biomet Microfixation, Inc.2010-11-08
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S004)Biomet Microfixation, Inc.2010-01-29
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S003)Biomet Microfixation, Inc.2009-10-21
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S002)Biomet Microfixation, Inc.2006-10-13